Table 4.
Toxicities and attributions
| Adverse Events | Grade 3 | Grade 4 | Grade 5 | Total |
|---|---|---|---|---|
| Abdominal Infection | 1 | 0 | 0 | 1 |
| Abdominal Pain | 5 | 1 | 1 | 7 |
| Acute Kidney Injury | 1 | 0 | 0 | 1 |
| Alanine Aminotransferase | 1 | 0 | 0 | 1 |
| Alkaline Phosphatase Increase | 1 | 0 | 0 | 1 |
| Anemia | 2 | 0 | 0 | 2 |
| Anorexia | 5 | 0 | 0 | 5 |
| Ascites, New | 8 | 0 | 0 | 8 |
| Bilirubin | 5 | 0 | 0 | 5 |
| Aspiration | 1 | 0 | 0 | 1 |
| Atrial Fibrillation | 1 | 0 | 1 | 2 |
| Chronic Kidney Injury | 1 | 0 | 0 | 1 |
| Death Not Otherwise Specified | 0 | 0 | 24 | 24 |
| Dehydration | 3 | 0 | 0 | 3 |
| Diarrhea | 2 | 0 | 0 | 2 |
| Duodenal Hemorrhage | 1 | 0 | 0 | 1 |
| Dyspnea | 1 | 0 | 0 | 1 |
| Edema, Cerebral | 0 | 1 | 0 | 1 |
| Edema, Limb | 0 | 1 | 0 | 1 |
| Encephalopathy | 1 | 0 | 0 | 1 |
| Fall | 1 | 0 | 0 | 1 |
| Febrile Neutropenia | 2 | 0 | 0 | 2 |
| Generalized Muscle Weakness | 4 | 0 | 0 | 4 |
| Headache | 1 | 0 | 0 | 1 |
| Hemorrhoids | 1 | 0 | 0 | 1 |
| Hepatic Failure | 0 | 0 | 1 | 1 |
| Hepatic Infection | 2 | 0 | 0 | 2 |
| Hyperglycemia | 1 | 0 | 0 | 1 |
| Hyperkalemia | 1 | 0 | 0 | 1 |
| Hypernatremia | 1 | 0 | 0 | 1 |
| Hypertension | 0 | 1 | 0 | 1 |
| Hyperuricemia | 1 | 1 | 0 | 2 |
| Hypokalemia | 2 | 2 | 0 | 4 |
| Hypophosphatemia | 1 | 0 | 0 | 1 |
| Hypoxia | 0 | 1 | 0 | 1 |
| Hypoxia | 0 | 1 | 0 | 1 |
| Ileus | 1 | 0 | 0 | 1 |
| Leukocytosis | 1 | 0 | 0 | 1 |
| Localized Edema | 1 | 0 | 0 | 1 |
| Lymphopenia | 1 | 0 | 0 | 1 |
| Nausea | 1 | 0 | 0 | 1 |
| Other | 11 | 1 | 4 | 16 |
| Pain | 1 | 0 | 0 | 1 |
| Penile Infection | 1 | 0 | 0 | 1 |
| Platelet Count Decreased | 1 | 2 | 0 | 3 |
| Pleural Effusion | 1 | 0 | 0 | 1 |
| Pneumonitis | 1 | 0 | 0 | 1 |
| Seizure | 1 | 0 | 0 | 1 |
| Sepsis | 2 | 1 | 0 | 3 |
| Small Intestinal Obstruction | 2 | 0 | 0 | 2 |
| Stroke | 1 | 0 | 0 | 1 |
| Surgical/Medical Procedures, Other | 1 | 0 | 0 | 1 |
| Syncope | 0 | 1 | 0 | 1 |
| Tricuspid Valve Disease | 1 | 0 | 0 | 1 |
| Tumor Lysis Syndrome | 1 | 0 | 0 | 1 |
| Urinary Tract Infection | 3 | 0 | 0 | 3 |
| Vomiting | 3 | 0 | 0 | 3 |
| Total | 94 | 14 | 31 | 139 |
| Attribution | ||||
| Definite | 12 | 0 | 1 | 13 |
| Probable | 5 | 2 | 0 | 7 |
| Possible | 0 | 0 | 0 | 0 |
| Unlikely | 12 | 3 | 3 | 18 |
| Unrelated | 37 | 6 | 26 | 69 |
| Unknown | 0 | 0 | 0 | 0 |
| Missing | 30 | 2 | 0 | 32 |